NCT04551365Completed
MicroFIBERgut: Effects of Lifestyle Changes and Chitosan on Gut Microbiota and Weight Management
Effects of Lifestyle Changes and Chitosan on Gut Microbiota Modulation, Body Weight and Important Health Markers in Selected Population Groups: A Double-blind, Block-randomized, Placebo-controlled Study
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
The purpose of this study is to compare the effects of chitosan diet supplementation to a placebo supplement on changes in gut microbiota, body weight and different health parameters among different population groups, being either obese (BMI 30-50) and undertaking major changes in lifestyle (patients) or being those not undergoing any major lifestyle changes (volunteers, BMI 18.5-35).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 10 Jul 2020
- Start date
- 15 Aug 2020
- Primary completion date
- 30 Oct 2023
- Lead sponsor
- University of Iceland
- Diseases
- Obesity
- NCT number
- NCT04551365
What you commit to
- Study type: Interventional
- Participants enrolled: 106
- From 15 Aug 2020 to the primary completion date, 30 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical procedures (abdominal and chest) or bariatric operation in the past 6 months
- Drug use: a) Drugs that can cause weight loss: SGLT2 inhibitors or GLP-1 analogs or other drugs simulating incretins in the digestive system for less than 3 months b) Warfarin
Other illness
- Eating disorders (i.e. anorexia, bulimia)
- Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
- History of poorly controlled diabetes mellitus or hypertension
- History of invasive fat reduction procedure (e.g. liposuction or abdominoplasty) within the past one year
- Shellfish allergy
Other
- Pregnant or breastfeeding
- Subjects taking or having taken diet pills or weight management supplements in past 30 days
- Use of antibiotics in the last 3 months
Who the study is looking for
- Block 1
- Women, 18-80 years old with BMI \>30 kg/m2, maximal supine width 65 cm.
- Living in the proximity (about 60 km radius) of Reykjavik
- Ready to stop any intake of probiotics (i.e. Bio-Kult) and weight control supplement during the trial period (3.5 months)
- Undertaking major lifestyle changes (diet and physical exercise)
- Not planning pregnancy during the treatment period (3 months)
- Block 2
- Women, 18-80 years old with BMI 18.5-35 kg/m2
- Living in the proximity (about 60 km radius) of Reykjavik
- Ready to stop any intake of probiotics (i.e. Bio-Kult) and weight control supplement during the trial period (3.5 months)
- Not undertaking any major changes in lifestyle
- Not planning pregnancy during the treatment period (3 months)
Age in the registry: 18 years to 80 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Reykjalundur, Rehabilitation Center Coordinator of this site? Confirm its status | Mosfellsbaer | Iceland | Unknown status |
Related publications
- Effect of Chitosan Supplementation and Lifestyle Changes on Health and Gut Microbiota in Icelandic Females With Obesity.Mol Nutr Food Res · 2026 · PMID 42522290
This page is information, not medical advice. Discuss any trial with your doctor.